NCT05004025CompletedPhase 1
Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma
Source: ClinicalTrials.gov · Last updated 15 Aug 2025
Brief summary (registry, in English)
Tumor Treating Fields targeted to liver metastases may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 16 Jun 2021
- Start date
- 28 Feb 2022
- Primary completion date
- 18 Nov 2024
- Lead sponsor
- HonorHealth Research Institute
- Diseases
- Melanoma
- NCT number
- NCT05004025
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 28 Feb 2022 to the primary completion date, 18 Nov 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous grade 3, life threatening immune related adverse event (irAE) from prior checkpoint inhibitor therapy
- Prior anti-cancer therapy (systemic, regional or radiation) within 2 weeks of C1D1 of study treatment
- AEs from prior anticancer therapies that have not resolved to grade 1 or less, other than endocrine related irAEs for which patients are on appropriate replacement therapy (ie hypothyroidism, adrenal insufficiency, type 1 diabetes)
- Serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
Other illness
- History of or active autoimmune disease requiring systemic corticosteroid or immunosuppressive therapy. (Patients who have limited autoimmune disease not requiring systemic therapy or autoimmune disease that is unlikely to recur, such as ulcerative colitis s/p colectomy, will be allowed to enroll.)
Lab values
- Prior treatment with anti cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4) therapy within 90 days of C1D1 of study treatment
Other
- Patient is unwilling or unable to comply with study procedures
- Patients with implanted pacemaker, defibrillator, nerve stimulator or other active electronic medical devices; sensitive to conductive hydrogels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes typically used for TTFields studies.
Who the study is looking for
- Patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant liver involvement
- Age 18 years or older and willing and able to provide informed consent
- WOCBP must have a negative serum pregnancy test documented with 72 hours of first administration of drug
- Sexually active and WOCBP, patient and partner must agree to use adequate contraception
- Normal organ and marrow function
- ECOG 0-1
- Life expectancy of 3 months or greater
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Angeles Clinic and Research Insititute Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| HonorHealth Research Institute Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.